SYDNEY, Aug. 22, 2024 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ⁶⁴Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions with suspected metastasis who are candidates for initial definitive therapy.

The FDA's Fast Track Designation is designed to expedite the development and regulatory review of novel drugs addressing serious conditions with significant unmet medical needs. For ⁶⁴Cu-SAR-bisPSMA, it provides a number of product development advantages. The designation paves the way for a potentially faster review process once Clarity submits its product approval application. Additionally, it enables more frequent communication with the FDA, allowing for rapid resolution of queries during development. Furthermore, Clarity can submit completed sections of its application as they are ready, rather than waiting for the entire package to be finished before it can be lodged with the FDA. These benefits would reduce the review time needed to bring this innovative prostate cancer imaging agent to market, potentially improving diagnosis and treatment planning for patients sooner.

Clarity's Executive Chairperson, Dr Alan Taylor, commented, "Receiving Fast Track Designation for ⁶⁴Cu-SAR-bisPSMA is a significant milestone, especially as we are actively recruiting into our first registrational Phase III trial, CLARIFY, and preparing for an End of Phase meeting with the FDA for a second pivotal Phase III trial with this product. The designation will allow us to work closely with the FDA to facilitate the development process, potentially accelerating the approval of this best-in-class diagnostic."

Clarity's ongoing clinical program with ⁶⁴Cu-SAR-bisPSMA includes trials in two indications: prostate cancer patients prior to undergoing radical prostatectomy, and with biochemical recurrence (BCR) of their disease. The completed Phase I PROPELLER study demonstrated favourable safety and efficacy results in patients with prostate cancer prior to radical prostatectomy. Driven by the compelling findings from the PROPELLER study, Clarity commenced a registrational Phase III trial in this patient population, CLARIFY, where recruitment is ongoing. In parallel, the Phase I/II trial, COBRA, ⁶⁴Cu-SAR-bisPSMA was found to be safe and highly effective in detecting prostate cancer lesions in patients with BCR. Based on the results from the COBRA study, Clarity commenced planning of a second registrational Phase III imaging trial. The Fast Track Designation is supported by the initial clinical evidence suggesting that ⁶⁴Cu-SAR-bisPSMA may offer improved lesion detection compared to existing prostate cancer diagnostics.